Functional Recovery in Stroke Patients With Task-Specific Robot-Aided Arm Therapy

NCT00719433 | Completed Phase 2

• 3 other identifiers: SNF ARMin III -1SNF 325200-120621EK-39/2007
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine whether task-oriented, robot-aided therapy is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in chronic hemiparetic stroke patients.

Conditions

Stroke; Upper Extremity Paresis

Keywords

stroke; chronic; rehabilitation; robot therapy; arm therapy

Outcome Measures

Primary Outcomes (1)

• Fugl Meyer Assessment Scale

  four and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up

Secondary Outcomes (2)

• Wolf Motor Function Test, Stroke Impact Scale, Motor Activity Log, modified Ashworth Scale, abnormal joint synergies, active range of motion (ROM), muscle strength, and spatial precision of hand positioning.

  three and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up

• fMRI

  before and after 8 weeks therapy, 2-months follow-up

Study Arms (2)

1

EXPERIMENTAL

Device: robot therapy (ARMin)

2

ACTIVE COMPARATOR

Other: conventional therapy

Interventions

robot therapy (ARMin) DEVICE

therapy of the affected arm with a robot for eight weeks, three times weekly for one hour

1

conventional therapy OTHER

physical and occupational therapy of the affected arm for eight weeks, three times weekly for one hour

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or more
• first-ever stroke (hemorrhagic or ischemic), verified by brain imaging
• stroke more than six months prior to the study
• termination of conventional therapy and stable recovery stage (outpatients)
• moderate to severe motor impairment of the arm (upper limb portion of FMA score between 8 and 38)
• ability to sit in a chair without any additional support and without leaning on the back rest
• written informed consent signed by the subject (or an authorized representative)

You may not qualify if:

• Excessive spasticity of the affected arm (mAS ≥ 3)
• any serious medical or psychiatric illness
• participation in any clinical investigation within 4 weeks prior to the start of this study
• anticipated need for any major surgery during the study
• women known to be pregnant or lactating
• Orthopedic, rheumatologic or other disease restricting movements of the paralyzed upper extremity
• shoulder subluxation (palpatory \> 2 fingers)
• diseased or damaged skin at the paralyzed arm
• inability to communicate effectively with the neurological examiner such that the validity of the patient's data could be compromised
• cyber sickness
• pace-maker or other implanted electric devices
• body weight \> 120kg
• serious cognitive deficits and aphasia preventing the performance of the ARMin treatment
• participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.

Sponsors & Collaborators

• University of Zurich: lead
• Sensory Motor Systems Lab, ETH Zurich: collaborator
• Balgrist University Hospital: collaborator
• Reha Rheinfelden: collaborator
• Zuercher Hoehenklinik Wald: collaborator

Study Sites (1)

University Hospital Balgrist

Zurich, Canton of Zurich, 8008, Switzerland

Location

Related Publications (3)

• Nef T, Mihelj M, Riener R. ARMin: a robot for patient-cooperative arm therapy. Med Biol Eng Comput. 2007 Sep;45(9):887-900. doi: 10.1007/s11517-007-0226-6. Epub 2007 Aug 3.

  PMID: 17674069 BACKGROUND

• Valero-Cuevas FJ, Klamroth-Marganska V, Winstein CJ, Riener R. Robot-assisted and conventional therapies produce distinct rehabilitative trends in stroke survivors. J Neuroeng Rehabil. 2016 Oct 11;13(1):92. doi: 10.1186/s12984-016-0199-5.

  PMID: 27724916 DERIVED

• Klamroth-Marganska V, Blanco J, Campen K, Curt A, Dietz V, Ettlin T, Felder M, Fellinghauer B, Guidali M, Kollmar A, Luft A, Nef T, Schuster-Amft C, Stahel W, Riener R. Three-dimensional, task-specific robot therapy of the arm after stroke: a multicentre, parallel-group randomised trial. Lancet Neurol. 2014 Feb;13(2):159-66. doi: 10.1016/S1474-4422(13)70305-3. Epub 2013 Dec 30.

  PMID: 24382580 DERIVED

MeSH Terms

Conditions

Stroke; Paresis; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Robert Riener, Prof.

  Sensory Motor Systems Lab, ETH Zürich

  STUDY DIRECTOR

• Armin Curt, Prof.

  Balgrist University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2008
• First Posted: July 21, 2008
• Study Start: July 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 22, 2013

Record last verified: 2013-04

Locations

CH (1)